Multi-layer pre-drape apparatus and process

ABSTRACT

A multi-layer pre-drape apparatus is applied to a patient before the patient is moved into the operating room. The multi-layer pre-drape apparatus includes a lower layer with a center aperture and an upper layer that covers the aperture. The multi-layer pre-drape apparatus can be placed on a sterilized area of the patient to maintain the cleanliness of the incision area. Alternatively, the multi-layer pre-drape apparatus can be placed on the patient and sterilization fluid can be applied to the skin of the patient through the aperture. The patient can then be moved into the operating room and the upper layer of the multi-layer pre-drape can be removed to expose the sterilized area of the patient in the aperture. Additional drapes can be added to the pre-drape apparatus.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to U.S. Provisional PatentApplication No. 62/249,703, “Multi-Layer Drape Apparatus And Process”which was filed on Nov. 2, 2015 and hereby incorporated by reference inits entirety.

BACKGROUND

Patient surgery can be very expensive. By making surgeries more timeefficient, the costs of surgeries can be reduced. Time in the operatingroom (OR) is expensive so reducing the time each patient needs in the ORwithout compromising the medical procedures in any way can reducesurgical costs. Much of this expensive time spent in the OR is due toprepping and draping the patient prior to their surgery. The OR is aspecialized sterile environment. In the OR environment, preparing orprepping of the surgical site is performed by OR personnel. The preppingprocess may include: applying an anti-bacterial solution to the skin ofthe patient, allowing the solution to dry on the skin and then applyingdraping materials to the skin of the patent.

Skin is a non-sterile tissue with a high bacterial count. Prepping ofthe skin refers to the treatment of the skin with specialized solutionsthat aim to reduce the bacterial count. The reduction of the bacterialcount in the skin is directly proportional to the duration of exposureto the cleansing solutions. The final step of prepping requires that thesolution on the skin be allowed to dry. Typical drying time may takeseveral minutes.

At the completion of prepping, the OR personnel then drapes the surgicalsite.

Draping consists of applying drape material in layers surrounding theincision site. Frequently, adhesive drapes are also applied to theincision site. Adhesive drapes such as 3M Loban are placed on the skinadjacent to the planned incision area so the drapes can preventmigration of bacterial contamination into the surgical site.

By current protocol embodiments, patients are admitted to a pre-surgicalunit prior to surgery. In the pre-surgical unit, the patients areprocessed and prepared before being transferred into the OR. Preparationof the patient includes the processing of the patient by nurses,physicians and administrative staff. Processes include interviewing andexamining the patient and may also include undressing the patient fromstreet clothes to place him or her in a surgical gown. As such, thepre-surgical unit is a non-sterile environment.

In some embodiments, patients are transferred to sub-sterile settingswhere anesthetic procedures are performed. These procedures include lineplacements or anesthetic blocks such as spinal or regional anesthesia.The costs of time for procedures performed in the pre-surgical unit canbe substantially lower than the costs of time for procedures performedin the OR.

The prepping and draping of the patient consumes valuable time in the ORat great expense to the hospital. For example, for total limb jointsurgical procedures, it may commonly take more than thirty minutes fromthe time the patient arrives in the OR until the surgeon makes the firstincision for the surgical procedure.

Current financial cost pressures are forcing hospitals to expedite workflows in the OR. This invention is directed towards new draping devices,technologies and methods that allow for the safe sterile and prepping ofsurgical sites outside of the OR environment as many hospitals do nothave space available for sub-sterile processing.

What are needed are methods and devices for safe sterile prepping anddraping of patients outside the OR in order to minimize the processingof the patient in the OR prior to the first surgical incision. Thepresent invention also describes devices that are modified for differentregions of the body to address an array of surgical procedures.

SUMMARY OF THE INVENTION

The present invention is directed towards a multi-layer pre-drapeapparatus and method. Rather than sterilizing an incision area of apatient in an operating room (OR), an area of a patient can besterilized outside of the OR and a multi-layer pre-drape apparatus canbe used to maintain the sterilization before the patient is moved intothe OR. Once the patient is within the OR, an upper layer of themulti-layer pre-drape apparatus can be removed to expose the sterilizedarea of the patient. Drapes can then be applied to the patient and thesurgical procedure can be performed.

In an embodiment, the multi-layer pre-drape apparatus can include anupper layer and a lower layer that has an aperture. The upper layer canbe adhesively secured to the lower layer and the upper layer can coverthe entire lower layer and the aperture. In different embodiments, thepre-drape apparatus can have various features such as integrated:drapes, sterilization fluids, sponge, storage areas, shelves, fluidports, needle ports, etc. The pre-drape apparatus can be stored in ahermetically sealed sterile package that can be opened when thepre-drape apparatus is ready to be used.

An area of a patient can be sterilized by scrubbing the area with asterile solution using a sponge or other mechanism. The sterile solutioncan then be allowed to dry on the area of the patient. The pre-drapeapparatus can be removed from its packaging. The lower surface of thelower layer can have an adhesive surface. An adhesive release liner canbe removed from the lower surface and the lower layer can be placed overthe sterilized area of the patient with the aperture of the lower layerover the incision area. Pressure can be applied to the pre-drapeapparatus to secure the adhesive to the skin of the patient.

In an embodiment, a pre-drape apparatus can be adhesively bonded to thepatient and a sterile solution can be used to clean the area of thepatient within the aperture. The sterile solution can be in a packetcontained within the pre-drape apparatus with a sponge or alternatively,the sterile solution may be injected through the upper layer into theaperture area. Once attached to the patent, the sterile solution can beused to sterile the patient. In an embodiment, the inner surface of theupper layer can be made of a sponge material that can absorb thesterilization solution and be pressed against the patient to clean theskin within the aperture of the lower layer.

In other embodiments, pre-drape apparatus can be a flexible structurethat can surround a limb of a patient to effectively contain the limbwithin a sealed bag. The pre-drape apparatus can include a sheet ofmaterial that has an adhesive around a perimeter portion of the sheet. Alimb can be placed over the sheet and the sheet can surround the limbwith the adhesive portions of the sheet forming a seal around the limb.The adhesive can also surround a proximal portion of the limb. In otherembodiments, the pre-drape apparatus can be a flexible bag having anopening that can have an adhesive seal. The limb can be placed into theopening and once fully inserted, the adhesive can be secured around thelimb.

A sterile solution can be used to clean the limb within the sealed bag.In an embodiment, the inner surface of the sheet can function like asponge which can absorb the sterile solution and can be pressed againstthe limb to perform the sterilization. Once the limb has beensterilized, the sealed bag can be coupled to a ventilation system whichcan direct air into the bag. Air can flow into the bag in an areaadjacent to the incision area so that the sterilization solution flowsaway from the incision area. The air and excess sterilization solutioncan flow out one or more air outlets coupled to the bag. The air flowcan dry the sterilization fluid on the limb. Once dry, the patient canbe moved into the OR and a portion of the bag over the incision area canbe removed. Drapes can be coupled to the bag before performing thesurgery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a three layer embodiment of apre-drape apparatus in a sterile package.

FIG. 2 illustrates a side view of a three layer embodiment of apre-drape apparatus having an aperture on a patient.

FIG. 3 illustrates a side view of two layers of a pre-drape apparatushaving an aperture on a patient.

FIG. 4 illustrates a side view of lower layer of a pre-drape apparatushaving an aperture on a patient.

FIG. 5 illustrates a side view of lower layer of a pre-drape apparatuson a patient with additional drapes attached to the lower layer.

FIG. 6 illustrates a side view of a two layer embodiment of a pre-drapeapparatus in a sterile package.

FIG. 7 illustrates a side view of a two layer embodiment of a pre-drapeapparatus having an aperture on a patient.

FIG. 8 illustrates a side view of a lower layer of a pre-drape apparatushaving an aperture on a patient.

FIG. 9 illustrates a side view of a lower layer of a pre-drape apparatuswith additional drapes attached around the aperture on a patient.

FIG. 10 illustrates a side view of a three layer embodiment of apre-drape apparatus on a patient.

FIG. 11 illustrates a side view of a middle layer and a lower layer of apre-drape apparatus on a patient.

FIG. 12 illustrates a side view of a lower layer of a pre-drapeapparatus having an aperture on a patient.

FIG. 13 illustrates a side view of a two layer embodiment of a pre-drapeapparatus having an aperture on a patient.

FIG. 14 illustrates a side view of two spaced apart layers of apre-drape apparatus having an aperture on a patient.

FIG. 15 illustrates a side view of a three layer embodiment of apre-drape apparatus where the upper layer and the middle layer areseparated.

FIG. 16 illustrates a side view of a three layer embodiment of apre-drape apparatus where the middle layer includes a rolled portion.

FIG. 17 illustrates a side view of a two layer embodiment of a pre-drapeapparatus where the lower layer includes a rolled portion.

FIG. 18 illustrates a side view of a three layer embodiment of apre-drape apparatus where the upper layer is larger than the middlelayer which is larger than the lower layer in a sterile package.

FIG. 19 illustrates a side view of a three layer embodiment of apre-drape apparatus where the upper layer is larger than the middlelayer which is larger than the lower layer placed on a patient.

FIG. 20 illustrates a side view of a middle layer and a lower layer on apatient.

FIG. 21 illustrates a side of a lower layer on a patient.

FIG. 22 illustrates a top view of a three layer embodiment of apre-drape apparatus where the upper layer is larger than the middlelayer which is larger than the lower layer.

FIG. 23 illustrates a side view of a pre-drape apparatus having a needleport.

FIG. 24 illustrates a top view of a pre-drape apparatus having a needleport.

FIG. 25 illustrates a side view of a two layer embodiment of a pre-drapeapparatus with a boundary material.

FIG. 26 illustrates a top view of a two layer embodiment of a pre-drapeapparatus with a boundary material.

FIG. 27 illustrates a top view of a two layer embodiment of a pre-drapeapparatus with a boundary material and additional drape material.

FIG. 28 illustrates a cross section side view of a multi-layerembodiment of a pre-drape apparatus with additional folded drapes.

FIG. 29 illustrates a cross section side view of a multi-layerembodiment of a pre-drape apparatus with folded drapes deployed.

FIG. 30 illustrates a cross section side view of a multi-layerembodiment of a pre-drape apparatus with folded drapes deployed.

FIG. 31 illustrates a bottom perspective view of an embodiment of themulti-layered pre-drape apparatus.

FIG. 32 illustrates a top exploded view of an embodiment of themulti-layered pre-drape apparatus on a patient.

FIG. 33 illustrates a side view of an embodiment of a multi-layeredpre-drape apparatus with a tent in a collapsed position on a patient.

FIG. 34 illustrates a side view of an embodiment of a multi-layeredpre-drape apparatus with a tent in an expanded position on a patient.

FIG. 35 illustrates a side view of an embodiment of a multi-layeredpre-drape apparatus with a tent in an expanded position with additionalfeatures on a patient.

FIG. 36 illustrates a top view of an embodiment of a multi-layeredpre-drape apparatus with a tent with additional features.

FIG. 37 illustrates a side view of a leg of a patient.

FIG. 38 illustrates a side view of leg placed in an embodiment of a prepextremity bag.

FIG. 39 illustrates a cross section view of a portion of an embodimentof a prep extremity bag.

FIG. 40 illustrates a side view of leg placed in an embodiment of a prepextremity bag with a drying mechanism.

FIG. 41 illustrates a top perspective view of a leg on a sheet thatforms a prep extremity bag.

FIG. 42 illustrates a top perspective view of a leg wrapped in a sheetthat forms a prep extremity bag.

FIG. 43 illustrates a side view of a leg wrapped in a sheet that forms aprep extremity bag.

FIGS. 44-46 illustrate cross section views of leg wrapped in a sheetthat forms a prep extremity bag.

FIG. 47 illustrates a side view of a leg in a partially cut prepextremity bag.

FIG. 48 illustrates a side view of a leg in a partially opened prepextremity bag with a shelf and additional drapes coupled to the prepextremity bag.

FIG. 49 illustrates a side view of a leg in a partially removed prepextremity bag.

FIG. 50 illustrates a side view of a leg in a sealed prep extremity bag.

FIG. 51 illustrates a side view of a leg in a sealed prep extremity bagduring drying.

FIGS. 52-54 illustrates a flow chart of a method for using the pre-drapeapparatus.

DETAILED DESCRIPTION

In an embodiment, a “pre-drape” apparatus can be applied to a patientprior to a surgical procedure. An area of surface skin on the patientcan be sterilized with a sterile solution such as: aqueous iodophor,aqueous CHG, alcohol iodophor, alcohol CHG, pHisoHex, pHisoDerm, iodineand any other suitable antiseptic solution. Alcohols have rapid activitywhen applied to the skin, but alone do not have a persistent, cumulativeactivity; however, when combined with another antiseptic agentpersistent, cumulative activity results. Therefore, a sterile solutioncan be a combination of alcohol and other antiseptic agent(alcohol-based solution). Alcohol-based solutions can have a greaterantimicrobial activity as compared to other solutions. Alcohol-basedsolutions can lower the microbial count on the skin more effectivelythan other solutions. For example, alcohol-based solutions that contain0.5% to 1% chlorhexidine gluconate have been found to have a persistentantimicrobial activity that is equal to, or greater, than that of CHGalone. Other effective sterile scrubbing agents include: chlorhexidinegluconate, iodophors, and triclosan.

The sterile solution can be applied to the skin of the patient tosterilize the skin around the surgical site. The sterility of thepatient's skin can be proportional to the amount of time of exposure tothe sterile solution. Thus, the skin will be more sterile when exposedlonger to the sterile solution. As discussed, OR time is very expensive.So if a substantial amount of time is required to sterilize a patient inthe OR, this use of time will be very expensive. In order to reduce thesterilization OR costs, it is not uncommon for the sterile solutionexposure time to be minimized. Thus, the sterilization process may notbe optimized in many surgical procedures. This lack of sterility isproblematic. Surgical site infection (SSI) complicates an estimated 5%of all clean-contaminated operations performed annually in US hospitalsand accounts for the most common nosocomial infection in surgicalpatients. Patients who develop SSI have longer and costlierhospitalizations and are more likely to spend time in an intensive careunit (ICU), are 5 times more likely to be readmitted, and are twice aslikely to die.

In an embodiment of the present invention, the sterility of the patientcan be substantially improved by performing the sterilization of thepatient prior to moving the patient into the OR. Thus, the inventiveprocess of applying the sterile solution to the patient outside the ORhas the benefits of: improving the sterility of the surgical field,reducing the likelihood of surgical site infection and reducing thecosts of the surgery. Since the patient's skin is sterilized outside theOR, the surgical procedure can be performed more quickly and no time isconsumed in the OR by the application of sterile solution to thepatient.

In some embodiments, the sterile solution is allowed to dry on thepatient and a pre-drape apparatus can be secured to the patient over thesterilized skin area. With reference to FIG. 1, a side view of apre-drape apparatus 100 in a sterile package is illustrated. Thepre-drape apparatus 100 may include an upper layer 115, a middle layer114 and a lower layer 113. The sterile package can include an upperpackage 109 and a lower package 111 that maintains the sterility of thepre-drape apparatus 100 until use. First a sterile adhesive 105 can beapplied in the interface between the lower surface of the upper layer115 and the upper surface of the lower layer 113 and a second sterileadhesive 103 can be applied to the lower surface of the lower layer 113.The lower package 111 may have an adhesive release film that is inphysical contact with a sterile adhesive 103 on the lower surface of thelower layer 113.

With reference to FIG. 2, the pre-drape apparatus 100 has been removedfrom the upper package 109 and placed on the skin 101 of the patient.The lower package release film has been separated from the adhesive 103on the lower surface of the lower layer 113. When the sterile releasefilm is removed, the sterile adhesive 103 is exposed and can be securedto the patient. When placed on the patient outside the OR, the outerupper surface of the upper layer 115 can be unsterile. However, allother surfaces including the lower surface of lower layer 113 and theinterface 105 between the lower surface of the upper layer 115 and theupper surface of the lower layer 113 can be sterile.

The multi-layered pre-drape apparatus 100 can have three or more layers113, 114, 115. In these embodiments, the interfaces 104, 105 between thedifferent layers 113, 114, 115 can be sterile adhesives. The differentlayers 113, 114, 115 can be attached to each other with differentadhesive strengths that can be progressively stronger with position inthe multi-layer stack. The highest strength adhesive 103 can be betweenthe lowest layer 113 and the skin 101, while the weakest strengthadhesive 105 can be between the upper most or outer most layer 115 andthe second outermost layer 114. In these embodiments, the multi-layeredpre-drape 100 can be configured to allow a user to sequentially removethe outer drape layer 115 and then the middle drape layer 113 and thenthe inner drape layer 113. More specifically, when the upper layer 115is pulled for removal, all of the adhesive layers 103, 104, 105 will beexposed to the same tensile forces. However, because the upper adhesivelayer 105 is the weakest pull off adhesion, only the upper layer 115will be removed when the tension force exceeds the pull off adhesion. Asthe layers 115, 114, 113 are sequentially removed, more force may berequired to exceed the increasing pull off adhesion forces.

In an embodiment, the pull off adhesion of each adhesive layer 103, 104and 105 can be quantified as in units of force/area such as pounds persquare inch. Thus, the upper adhesive 105 between the upper layer 115and the lower layer 113 may have a pull of adhesion of 0.5 PSI or lesswhich is lower than the middle adhesive 104 which may have a pull offadhesion of 0.75 PSI or less and the lower adhesive 103 between the skinand the lower layer 113 which may have a pull off adhesion of 1.0 PSI orless.

Table 1 is an example of adhesive strengths for a 2 layer pre-drapestructure and Table 2 is an example of adhesive strengths for a 3 layerpre-drape structure. In other embodiments, a drape apparatus can haveany number of layers with the described progressive change in pull offadhesive strengths. In these tables examples of the pull off adhesionvalues are listed. In other embodiments, any other suitable pull offadhesion values can be used as long as the different adhesive layershave progressively stronger pull off adhesion strengths. The upperlimits of pull off adhesion should allow the lowest layer to be removedfrom the patient's skin without causing any damage to the skin.

In an embodiment, the adhesives may be more strongly bonded to the lowersurfaces of the multiple different layers. When each layer is removed,all of the newly adhesive material that has been exposed can be removedas well. This concept can be similar to a “post it” where the adhesivedoes not leave the paper or tape. This feature will leave a clean layeron the newly exposed upper layer. By not having any adhesive remainingon the exposed upper surfaces of the layers, the surgical field will befree of adhesive materials. In some embodiments, an adhesive solvent canbe used to dissolve the adhesive below the lowest layer. This dissolvingprocess can be useful when a drape needs to be removed from a patientwith sensitive, weak and/or thin skin. Once the adhesive has beenremoved, the layer can be pulled from the skin without causing anytearing damage to the skin.

TABLE 1 Interface Pull Off Adhesion Layer 1 to Layer 2 1-2 PSI Layer 2to Skin 4-5 PSI

TABLE 2 Interface Pull Off Adhesion Layer 1 to Layer 2 1-2 PSI Layer 2to Layer 3 3-4 PSI Layer 3 to Skin 5-6 PSI

In an embodiment, a layer removal process can be performed to avoiddamage to the skin 101 of the patient. A designated corner can be pulledaway from the underlying layer 114 in a progressive peeling motion. Theadhesive removal can proceed across the contact area so that only asmall area of adhesive is being removed at any time. Because only asmall area is being pulled away at one time, the force required toremove each layer may not be more than a pound or less and the pressureapplied to the skin is minimal. In an embodiment, the designated removalstarting corner can be marked or designated as a tab. The adhesive inthe removal corner can be weaker or omitted so that the starting cornercan be easily peeled away. In an embodiment, the adhesive 105 can besecured to the upper layer 115 so that when the upper layer 115 ispulled away from the middle layer 114, the adhesive 105 is also removed.The upper surface of the middle layer 114 can have a release filmmaterial surface such as wax paper or plastic. In other embodiments, itcan be desirable to have the adhesive 105 remain on the middle layer 113so that added drapes can be secured to the lower layer 113.

With reference to FIG. 3, the patient may be moved into the OR and upperlayer which is unsterile has been removed. The sterile middle layer 114is now exposed which covers the aperture 117. The adhesive 104 can besecured to the middle layer 114 so that when the middle layer 114 ispulled away from the lower layer 113, the adhesive 104 is also removed.The upper surface of the lower layer 113 can have a release filmmaterial. With reference to FIG. 4, the patient is in the OR and themiddle layer 114 has been removed. The lower layer 113 and the skin area107 within the aperture 117 are exposed.

In addition to having different adhesive strengths, the different layerscan be color coded to illustrate the sterility of the pre-drapeapparatus 100. As discussed, the pre-drape apparatus 100 can be appliedto the patient outside of the OR. Thus, the upper surface of the upperlayer 115 is non-sterile. The patient can be moved into the OR beforethe upper layer 115 is removed and the upper layer of the middle layer114 can be sterile. When the surgeon is ready to cut the patient, themiddle layer 114 can be removed and the upper lower layer 113 can alsobe sterile. In an embodiment, the sterile and non-sterile status of thedifferent layers can be identified visually. For example, a non-sterilelayer can be designated with a first color such as yellow and a sterilelayer can be designated with a second color such as green. In theillustrated example, the upper surface of the upper layer 115 can be afirst color (yellow) to designate that it is non-sterile. The uppersurfaces of the middle layer 114 and the lower layer 113 can be green toindicate that these surfaces are sterile. In other embodiments, theupper surfaces of the different layers can be marked with text which cansimply state, “sterile” or “non-sterile.” By looking at the colors ofthe layers, the OR staff can distinguish the non-sterile upper layer 115from the sterile middle layer 114.

With reference to FIG. 5, in some embodiments, it can be desirable tohave the adhesive remain on the upper surface of the lower layer 113 sothat added drapes 121 can be secured to the lower layer 113 around theaperture 117. Alternatively, an adhesive can be placed on the contactareas of the added drapes 121 and the lower layer 113 to create a sealbetween at the areas 129 where the drapes 121 and the lower layer 113overlap. The added drapes 121 can then rest on the skin 101 of thepatient around the lower layer 113.

While the pre-drape apparatus shown in FIGS. 1-4 illustrate layers thatare all the same size, in other embodiments, the layers of the pre-drapeapparatus can have various sizes. FIG. 6 illustrates a sterile two layerpre-drape apparatus 100 in a package that includes the upper package 109and a lower package 111 which may have a release film attached to theadhesive 103 on the lower surface of the lower layer 113 and theadhesive 105 on the lower layer of the upper layer 115. In this example,the upper layer 115 is larger than the lower layer 113 and overlaps theouter perimeter of the lower layer 113.

With reference to FIG. 7, the pre-drape apparatus 100 has been removedfrom the package and placed on the skin 101 of the patient with theaperture 117 over the incision area of the skin 107 outside of the OR.The adhesive 103 holds the lower layer 113 to the skin 101 and theadhesive 105 holes the upper layer 115 to the skin 101 around theperimeter of the lower layer 113. With reference to FIG. 8, the patientcan be moved into the OR and the upper layer has been removed. The lowerlayer 113 and the incision area of the skin 107 are exposed. Withreference to FIG. 9, it can be desirable to keep the adhesive on theupper layer of the lower layer 113. Additional drapes 121 can be placedon the lower layer 113. The adhesive 105 can create a seal between atthe areas 129 where the drapes 121 and the lower layer 113 contact eachother and overlap.

With reference to FIG. 10, a three layer pre-drape apparatus 100 isillustrated. In this embodiment, the upper layer 115 and the middlelayer 114 can be larger than the lower layer 113. The upper layer 115can be held to the middle layer 114 with an adhesive 105 and the middlelayer 114 can be held to the lower layer 113 with an adhesive 104 thatcan have a lower bonding strength as described above. The three layerpre-drape apparatus 100 can be placed on the skin 101 of the patientoutside of the OR. With reference to FIG. 11, the upper layer 115 hasbeen removed and the middle layer 114 is exposed. With reference to FIG.12, the patient can be moved into the OR and the middle layer 114 isremoved to expose the lower layer 113 and the incision area of the skin107 in the aperture 117.

With reference to FIG. 13, another embodiment of a two layer pre-drapeapparatus 100 is illustrated having a lower layer 113 and an upper layer115 that is larger than the lower layer 113 and extends over theperimeter of the lower layer 113. In the illustrated embodiment, thepre-drape apparatus 100 can be placed on a patient with the aperture 117over an incision area of the skin 107 outside the OR. The upper layer115 is exposed and non-sterile. The patient can then be moved into theOR and the upper layer 115 can be removed to expose the lower layer 113,the aperture 117 and the incision area of the skin 107.

With reference to FIG. 14, in an embodiment, it is possible to have amulti-layer pre-drape apparatus 100 where the upper layer 115 and thelower layer 113 are not in direct physical contact. In the illustratedembodiment, the upper layer 115 and the lower layer 113 can be separatedby a space. The upper layer 115 can be adhesively bonded to the skin toform a seal around the lower layer 113 to maintain the sterility of thelower layer 113 and the skin under the upper layer 115. The lower layer113 can be coupled to the skin with an adhesive 103. In this embodiment,an adhesive may not exist in the area between the upper layer 115 andthe lower layer 113. In an embodiment, the space can be created withsterile gas pressure, which can be injected between the upper layer 115and the lower layer 113. After the patient is moved into the OR, theupper layer 115 can be removed to expose the lower layer 113, theaperture 117 and the incision area of the skin 107.

With reference to FIG. 15, the multi-layer pre-drape apparatus caninclude a lower layer 113 that is held to the middle layer 114 with anadhesive 104. The upper layer 115 and the middle layer 114 can beseparated by a space. The upper layer 115 can be adhesively bonded tothe skin to form a seal around the middle layer 114 and the lower layer113 to maintain the sterility of the middle layer 114 and the lowerlayer 113 and the skin under the upper layer 115. The lower layer 113can be coupled to the skin with an adhesive 103. In this embodiment, anadhesive may not exist in the area between the upper layer 115 and themiddle layer 114. In an embodiment, the space can be created withsterile gas pressure, which can be injected between the upper layer 115and the middle layer 114. The upper layer 115 can be removed to exposethe middle layer 114, the lower layer 113, the aperture 117 and theincision area of the skin 107. After the patient is moved into the OR,the middle layer 114 can be removed to expose the lower layer 113, theaperture 117 and the incision area of the skin 107.

With reference to FIG. 16, the multi-layer pre-drape apparatus caninclude an upper layer 115, a rolled drape layer 133 and a lower layer113. The upper layer 115 can be larger than the lower layer 113 and therolled drape layer 133 can be larger than the upper layer 115 in itsexpanded state but small in area in a rolled state (as shown). Thepre-drape apparatus can be placed on the patient outside of the OR withthe aperture 117 of the lower layer 113 over an incision area of theskin 107. An adhesive 103 can hold the lower layer 113 to the patient.When the patient is moved into the OR, the upper layer 115 can beremoved and the rolled drape layer 133 can be unrolled. The lower layer113, the aperture 117 and the incision area of the skin 107 can also beexposed.

With reference to FIG. 17, in an embodiment, the multi-layer pre-drapeapparatus can include an upper layer 115 and a rolled drape 133 that hasan aperture 117 that surrounds an incision area of the skin 107 of thepatient. The rolled drape 113 can be secured to the patient with anadhesive 128. When the patient is moved into the OR, the upper layer 115can be removed and the rolled drape layer 133 can be unrolled. Theaperture 117 and the incision area of the skin 107 can also be exposed.

With reference to FIG. 18, a multi-layer pre-drape apparatus in asterile package having an upper package 109 and a lower package 111 isillustrated. In this embodiment, the upper layer 115 is larger than themiddle layer 114 which is larger than the lower layer 113 which includesan aperture 117. With reference to FIG. 19, the multi-layer pre-drapeapparatus is removed from the sterile package and placed on the skin 101of a patient with the aperture 117 over the incision area of the skin107. An adhesive 104 can secure the middle layer 114 to the skin 101 andform a seal around the lower layer 113 and an adhesive 105 can securethe upper layer 115 to the skin and form a seal around the middle layer114. With reference to FIG. 20, the upper layer 115 has been removed toexpose the middle layer 114. With reference to FIG. 21, the patient hasbeen moved into the OR and the middle layer 114 can be removed to exposethe lower layer 113, the aperture 117 and the incision area of the skin107. FIG. 22 illustrates a top view of the multi-layer pre-drapeapparatus showing that the upper layer 115 is larger than the middlelayer 114 which is larger than the lower layer 113 which includes anaperture 117.

FIG. 23 illustrates a side view and FIG. 24 illustrates a top view of atwo layer embodiment of a pre-drape apparatus 100. In this embodiment,the upper layer 115 can be attached over a lower layer 113 that coversan aperture 117. The upper layer 115 can include a needle port 161 whichcan allow a needle 163 to be inserted into the aperture 117. The needle163 can be coupled to a syringe that can inject a sterilization solutioninto the aperture 117 volume. Alternatively, the needle 163 can bepressed into the skin 101 of the patient so that medication can be givento the patient. The needle port 161 can include a seal that is onlyopened when the needle 163 is inserted. When the needle 163 is removed,the needle port 161 is sealed to prevent fluids (liquids and gas) fromentering or exiting the aperture 117 space.

In different embodiments, the aperture 117 can have differentconfigurations. For example, the lower layer 113 can be made of athicker material which can allow more ambient air to be above theincision zone and cause the upper layer 115 to be higher away from theskin 101 so that there is less chance of contact. In a preferredembodiment, the portion of the upper layer 115 above the incision zoneskin area 107 does not have an adhesive so the upper layer 115 will notstick to the incision zone skin area 107. This area above the incisionzone skin area 107 can also form a volume within which the sterilizationprep solution can be held or injected. Thus, the skin 101 can form thelower surface and the upper first layer 115 can form the upper volumesurface. In this embodiment, the lower layer 113 or the edges of theaperture 117 can be non-absorptive so that the lower layer 113 can holdor contain the sterilization prep solution above the incision zone skinarea 107. In this embodiment, the upper layer 115 and the lower layer113 can be made of non-absorptive materials and the lower adhesive 103and the adhesive 105 between the upper layer 115 and the lower layer 113can create a liquid containment volume 117. The sterilizing solution isheld within the incision zone skin area 107.

In different embodiments, the sterilizing solution can be added atvarious times and through a nozzle on to the incision zone skin area 107through the drape apparatus 100. The sterilizing solution can be a gelor fluid injected into the aperture region 117. A gel can have a thickerconsistency which may tend to stick to the incision zone skin area 107and may be less easily absorbed by the drape 100 material and pulledaway from the incision zone. In an embodiment, a sponge or otherstructure can be saturated with a sterilizing solution and held in placein the aperture volume 117 above the incision zone skin area 107.

In other embodiments, a nozzle can be attached to or integrated with theupper layer 115 or the lower layer 113 to allow the sterilizing solutionto flow into the volume above the incision zone. For example, the nozzlecan replace the needle port 161 in the upper layer 115. The nozzle caninclude a valve to prevent the sterilization solution from exiting theincision zone. In an embodiment, the process can include the steps of:opening the valve, pumping the sterilizing solution into the volumeabove the incision zone skin area 107 and closing the valve to retainthe sterilizing solution above the incision zone skin area 107. Theseembodiments, allow the skin area 107 to soak in the sterilizing solutionfrom time of application until the outer drape 115 is removed.

In different embodiments, the use of the inventive multi-layer drapescan be described as part of a process that can improve efficiency andsterility in the OR. The skin of the patient can be sterilized and themulti-layer drape can be applied to the patient in a pre-surgery nonsterile area of the facility (hospital). The outer surface of the upperlayer can be non-sterile and all underlying layers and surfaces can besterile. Once the patient is transferred to the OR the outer layer ofdrape can be removed, exposing the underlying sterile layer(s). Ifnecessary, additional layers of drapes can be applied to the sterilelayer(s). Since the patient's skin is sterilized and the drapes areapplied out of the OR, the time in the OR is reduced and the costefficiency of the surgery is improved. The sterilization time of thepatient's skin is also longer which improves sterilization and reducethe chances of infection.

In other method embodiments, the outer drape layer of the multi-layerdrape apparatus is removed and the aperture area in the lower drapelayer is exposed. The air exposure allows the sterilizing prep solutionin the aperture to dry. The surgeon can mark the skin on the incisionarea with marker to identify an incision line(s) and an adhesive drapecan be applied to the aperture and the surgical procedure can bestarted.

In an embodiment, it can be desirable to allow the skin to soak for aslong as possible in the prep solution to reduce the bacterial countprior to the procedure. When this soaking procedure is performed, theprep time can be extended from 3 minutes to 20-30 minutes. Thistechnique still allows the surgeon to mark the incision site in the ORafter the patient has been positioned. It reduces the draping procedureto applying a single strip of adhesive drape to a limited space in theregion of the incision.

Soaking of the skin with sterilizing prep solution can be performed witha pre-drape apparatus having an aperture. In an embodiment, theinventive system can use an aperture pre-drape apparatus, which includesan aperture opening in the lower layer and an upper layer 115 thatcovers the lower layer and the aperture 117. In this embodiment a prepsolution can be applied to the patient over the incision zone of theskin 101 and the prep solution can dry on the patient. The multi-layerpre-drape can be placed on the patient with the aperture 117 of thelower layer aligned over the incision zone. In an embodiment, theadhesive on the lower surface of the lower layer 113 can be covered witha release paper. The release paper can be removed to expose the adhesiveand the multi-layer pre-drape 100 is applied to the patient with theaperture 117 over the incision zone. In this embodiment, the uppersurface of the upper layer 115 is non-sterile and exposed to ambient airoutside the OR while all other surfaces of the multi-layer drape 100 aresterile including the adhesive on the lower surface of the lower layer113 and the adhesive on the interface between the upper layer 115 andlower layer 113. In an embodiment, the aperture 117 may hold thesterilization solution, which can be in the form of a gel, held within asponge or other fluid containing structure placed in the aperture 117, aporous receptacle, or any other fluid absorbing structure that will keepthe fluid in contact with the incision zone of the skin 101.

FIG. 25 illustrates a side view and FIG. 26 illustrates a top view of anembodiment of a multi-layered pre-drape apparatus 100 that can include a“boundary material” 119 between upper layer 115 and the lower layer 113.In the illustrated example, the boundary material 119 can be a strongermaterial with a thin thickness such as a sheet of plastic material thatis adhesively bonded to the lower drape layer 113. The boundary material119 can have a shape that matches the outer perimeter of the upper layer115 and the lower layer 113. The boundary material 119 also has an inneropening that is larger than the aperture 117 in the lower drape layer113. The multi-layer pre-drape apparatus 100 can be applied to theincision zone of the patient as described above. When the upper layer ispulled off 115, the underlying drape 113 is exposed and the boundarymaterial 119 can be expanded outward. The surgeon can then applyadditional drapes to the boundary material 119 that can expand furtheracross the patient than the multi-layered pre-drape 100. The additionaldrapes can be made of a durable material and have an adhesive edge whichis secured to the boundary layer 119. In different embodiments, theadditional drapes can be made of various materials such as: plasticslike Tyvex, cloth or any other suitable durable protective materials.

FIG. 27 illustrates a top view of an embodiment of the additional drapematerial 121 attached to the boundary material 119 that is attached to alower layer 113 with an aperture 117. The additional drape 121 caninclude an aperture that is smaller than the perimeter of the boundarymaterial 119. An adhesive can be applied to the edge of the boundarymaterial 119 which can be used to secure the additional drape 121 to theboundary material 119. The adhesive can create a fluid tight seal, whichprevents fluids from flowing from the upper surface of the boundarymaterial 119 through the interface with the additional drape 121.

In some embodiments, the additional drapes can be integrated into themulti-layer pre-drape apparatus. FIG. 28 illustrates a cross sectionalview of a three-layer embodiment of a pre-drape apparatus where thelower layer 113 is a planar structure as described above. The middlelayer boundary material 119 includes a flat section that surrounds thesurgical incision zone skin area or aperture 117 and is attached to theperimeter boundary material 119 that can be folded into draped sections127 in an accordion manner. The upper layer can be a sterile cover 123that can be flat over the middle incision zone 117 and raised over thefolded draped sections 127. The upper layer 123 can function as a coverand hold the boundary material 119 and folded drape sections 127 inplace. In an embodiment, the middle planar area can have an apertureopening 117 in the lower layer 113 and the boundary material 119. Theupper drape 123 can cover the aperture 117. This embodiment of themulti-layer drape can be secured to the patient's skin 101 in the samemanner as described above. The outer surface of the upper layer drape123 can be non-sterile while all other lower layers and interfacesbetween the different layers can be sterile. With reference to FIG. 29,when the perimeter of the upper layer 123 is opened, the folded sections127 of the middle drape layer can be unfolded and expanded over thesides of the patient. With reference to FIG. 30, when the foldedsections 127 have been fully expanded, the center portion of the upperlayer 123 can be removed to expose the aperture 117. The describedprocess can simplify and speed the preparation of the patient prior tothe surgical incision.

With reference to FIG. 31, a bottom perspective view of an embodiment ofthe multi-layered pre-drape apparatus is illustrated. The bottom of thelower layer 113 having an adhesive surface 103 is illustrated which isattached to the skin of the patient. The middle portion of the lowerlayer 113 includes an aperture 117 which can hold a sterilizing prepsolution. The outer surface of the lower layer is sterile and attachedto an upper layer 115. With reference to FIG. 32, an illustration of howthe multi-layered pre-drape can be attached to a patient 131 isillustrated. As discussed, the lower layer 113 with an aperture 117 canbe attached to the skin 101 of the patient 131, in this example the backof a patient 131. The aperture 117 of the lower layer 113 can be overthe incision zone. The upper surface of the lower layer 113 can becovered with an upper layer 115. The upper surface of the upper layer115 can be non-sterile while the lower layer 113 and interfaces aresterile. The skin 101 of the patient 131 can be sterilized as describedand the multi-layered pre-drape can be secured to the patient 131outside the OR. When the patient 131 is moved into the OR, the upperlayer 115 can be removed to expose the sterilized lower layer 115 andincision zone of the patient 131.

FIG. 33 illustrates a side view of an embodiment of a multi-layerpre-drape apparatus that includes an expandable tent mechanism 165 thatis in a compressed configuration. The lower layer 113 can be attached tothe upper layer 115 and the tent mechanism 165 can be coupled over theaperture 117 that can extend through both the upper layer 115 and thelower layer 113. The tent mechanism 165 can be transparent so that thesurgical area of the skin 101 is visible.

FIG. 34 illustrates a side view of an embodiment of a multi-layerpre-drape apparatus that includes an expandable tent mechanism 165 thatis in an expanded configuration. In this embodiment, the tent mechanism165 can include an accordion type of expansion walls that has beenpulled up away from the skin 101. This creates a larger volume over theaperture 117 which can be used to perform tasks on the surgical areaprior to moving the patient to the OR. In an embodiment, a mechanism 166such as a pole or support can be used to hold the tent mechanism 165 inthe expanded configuration.

FIG. 35 illustrates a side view and FIG. 36 illustrates a top view of anembodiment of a multi-layer pre-drape apparatus that includes anexpandable tent mechanism 165 that is in an expanded configuration thatincludes additional features. In this example, the tent mechanism 165can include a shelf 170 for storing tools such as sponges andsterilization solutions. The tent mechanism 165 can include grip inserts167 which can be used to grip a tool 169. In the illustrated example,the tool 169 can be a sponge that can be saturated with a sterilizationsolution. The tool 169 can have a handle that can be controlled by usersthrough the grip inserts 167 to scrub and sterilize the skin 101 in theaperture 117. When the scrubbing is complete, the tool 169 can be placedon the shelf 170 so that the skin can dry. In an embodiment, the tentmechanism 165 can be coupled to a ventilation system that can circulateair to dry the skin 101.

In other embodiments, a prep bag can be used to sterilize a limb of apatient. FIG. 37 illustrates a leg 135 of a patient and FIG. 38illustrates a leg 135 that is placed in a prep extremity bag 137 whereit can be sterilized prior to a surgical procedure. The inventive systemutilizes various prepping technologies. In an embodiment, the componentsof the present invention can be contained within the prep extremity bag137. A circular seal 139 can be placed around the circumference of theleg 135 above the knee to seal the contents within the prep extremitybag 137 to maintain sterility. The prep extremity bag 137 can be anelongated closed end tubular structure that includes a seal at an openend of the bag. The bag 137 can be pulled onto the leg 135 or limb oralternatively, the bag 137 can be rolled onto the leg 135 or limb.

In different embodiments, these extremity bags can contain variouscombinations of components such as at least one of the following:sponge, inflation mechanism, air drying mechanism, and drapes withapertures. The extremity bag can include sponge integration, which canabsorb and be used to scrub and sterilize the skin of the patient. Withreference to FIG. 39, a side view of a portion of a prep extremity bagis illustrated that includes an outer shell material 140 which can bebonded to an inner sponge liner 142 that can line the entire innersurface of the prep extremity bag or at least a portion of the prepextremity bag. The shell material 140 can be a flexible plastic materialthat is impermeable to liquids including the sterilizing prep solutions.In contrast, the inner sponge liner 142 can be a porous structure thatcan absorb sterilizing prep solutions. A distal portion of a limb of apatient can be placed in the prep extremity bag and a seal can besecured to a proximal portion of the limb. A sterilizing prep solutioncan be placed within the extremity bag and the outer surface of theextremity bag can be manipulated to press the inner sponge liner againstthe limb so that the limb can be scrubbed with the sterilizing prepsolution and sponge liner.

With reference to FIG. 40, the leg 135 can be dried after beingsterilized with inflation technology and air drying technology. An airinlet 141 and air outlet(s) 143, 144 can be coupled to the prepextremity bag 137. The air inlet 141 can be coupled to a pump which canpump dry filtered sterile air into the extremity bag 137 which can drythe leg 135 or limb after sterilization fluid exposure. The air inlet(s)141 and outlet(s) 143, 144 can be apertures formed in the prep extremitybag 137 to allow for air flow over the leg 135. The arrows in FIG. 40can illustrate the air flow over the leg 135 and through the extremitybag 137. The inlet aperture can be located close to the incision area sothe air flows away from the incision area. In the illustratedembodiment, the incision zone may be on the front of the patient's kneeand the inlet 141 can be directly over the knee. The outlets 143, 144can be on the opposite ends of the bag 137. In this example, there is anupper outlet 143 on a proximal portion and a lower outlet 144 on adistal portion of the bag 137. The drying air can exit through the upperoutlet 143 and the lower outlet 144 can be configured to drain anyresidual sterilization solution from the bag 137. As long as the inletpressure is higher than the ambient pressure outside the bag 137, theair and fluids will flow out of the outlets 143, 144 and the limb 135will remain sterile. The leg 135 may be elevated to reduce the contactarea between the leg 135 and the extremity bag 137. When the leg 135 hasdried, the patient can be moved into the OR and the bag 137 or a portionof the bag 137 can be opened to expose the incision zone or the bag 137can be opened at an aperture incision site. As discussed, thesterilization of the skin can be proportional to the exposure time tothe sterilization solution. A longer exposure time to the sterilizationsolution will reduce the likelihood of infection. Because the exposuretime is outside the OR, the cost of this sterilization process isreduced.

In an embodiment, when the bag is opened, any drapes that are integratedwith the bag can be unfolded. Alternatively, the bag can be removed andsterile pre-drapes can be applied to the patient. The bag can also becombined with new sterile drapes, which can be integrated or added tothe bag with an adhesive. Although the figures illustrate a legembodiment, in other embodiments, the bag can be used with arms.

Another example of an extremity bag is illustrated with reference toFIGS. 41-48. A limb sterilization bag can be formed from a sheet 147which is wrapped around the limb 135 and sealed. In differentembodiments, the limb 135 can be cleaned with a sterile solution and canbe immediately sealed in a sterile bag 147 so that the limb 135 willremain sterile before the patient is moved into the OR. With referenceto FIG. 41, a leg 135 of a patient on a sheet 147 that is used to formthe extremity bag is illustrated. The leg 135 can be placed with anincision zone over a non-adhesive area 151 of the sheet 147. Thenon-adhesive area 151 can be surrounded by an adhesive area 149. Withreference to FIG. 42, the uniform thickness sheet 147 is wrapped aroundthe leg 135 in such a way that the adhesive areas 149 of the sheet 147are aligned with each other and the non-adhesive areas 151 can bealigned with each other. With reference to FIG. 43, a side view of thesheet 147 wrapped around the leg 135 is illustrated. The adhesive areas149 on one side of the sheet 147 can be attached to portions of the leg135 and the adhesive areas 149 on the opposite side of the sheet 147above the leg 135. The non-adhesive areas 151 can surround the incisionzone of the leg 135 but not adhere to the incision zone. The adhesivearea 149 side surfaces of the bag can be secured to each other andsealed around the limb 135 with a contained volume. This bag sealing canbe achieved through the adhesive areas 149 that are on the inner surfaceof the sheet material 147 that are secured to each other and the limb135. The sheet 147 can be transparent so the user can see the limb 135while the material is wrapped around the limb 135.

FIG. 44 illustrates a cross sectional view of a distal portion of anembodiment of the prep bag sheet 147 at the ankle portion of the leg135. The adhesive areas 149 can form a seal with the ankle to preventliquids from flowing out of the incision area and the bag. FIG. 45illustrates a cross sectional view of a knee portion of the prep bagsheet 147 that can be partially inflated so that the sheet 147 is not incontact with the upper and side portions of the leg 135. In anembodiment, the non-adhesive portions 151 can include a solid flexibleshell and a sponge liner, which can be saturated or impregnated with thesterilization solution. The leg can be sterilized by pressing the spongeliner against the leg so that the prep solution sterilizes the skin.FIG. 46 illustrates a cross sectional view of a distal portion of anembodiment of the prep bag sheet 147 at the thigh portion of the leg135.

The described prep sterilization bags can used to sterilize limbs usingvarious different methods. In the first embodiment, the bag can besecured around the limb of the patient. The open end of the bag can besealed around the limb and the sterilization solution can be injectedinto the bag. The limb can then be scrubbed with the sponge on the innersurface of the bag and then the patient can be moved into the OR and thebag can be removed allowing the limb to then air dry in a sterile ORenvironment.

In another embodiment, the bag can be secured around the limb of thepatient and the open end of the bag can be sealed around the limb. Thesterilization solution can be injected into the bag and the limb canthen be scrubbed with the sponge on the inner surface of the bag. An airhose which supplied clean sterile air can be coupled to the bag and thesterile air can be pumped through the bag. The air can absorb thesterilization solution, which can dry on the limb within the sterilebag. The patient can then be moved into the OR and the bag can beremoved to expose the dry and sterile limb.

In another embodiment, a sterilization solution can be injected into thebag and a sponge can be sealed within the bag with the limb. The limbcan be scrubbed with the sponge and sterilization solution. The patientcan be moved into the OR and the bag can be opened so to allow the limbto dry in the OR. Alternatively, inputs and outputs can be coupled tothe bag and the limb can be dried in the bag as described above.

In some embodiments as shown in FIG. 43, the inner surface of the prepbag can have non-uniform adhesive surfaces 151. The areas of the sheetthat are adjacent to the surgical incision zone can be free of adhesivesso that the adhesive will not stick to the limb 135 at the surgicalsite. The areas of the bag 153 surrounding the incision zone of the limb135 can be covered with an adhesive so that when the bag 153 sticks tothe limb 135 and forms a liquid seal with the bag 153. The locations ofthe adhesives 149 can be marked so that the bag 153 can be moreaccurately positioned on the patient's limb 135. The edges of the sheet147 are sealed to each other to form a bag 153 around the limb andexcess air can be removed from the bag 153. The adhesive portions of thesheet 147 can be closely attached to the limb and the non-adhesive 151portions will not be attached to the limb. FIG. 19 illustrates a sideview of a bagged leg 135 which shows the line that separates theadhesive areas 149 and the non-adhesive area 151. The upper edge of thebag 153 is sealed so that the limb 135 is sealed within the bag 153. Inthe illustrated embodiment, the surgical procedure is being performed onthe knee where the bag 153 loosely surrounds the knee.

With reference to FIG. 47, the patient can be moved into the OR and theknee portion of the bag 153 has been completely removed to expose theknee of the leg 135 for the surgical procedure. With reference to FIG.48, a portion of the bag 153 above the front of the knee has been openedto expose the limb. The bag 153 may have features which are exposed whenthe bag 153 is opened. For example, in the illustrated embodiment, ashelf 159 has been built into the bag 153 that is usable when the bag153 is opened. The shelf 159 can be used to temporarily place objectsduring surgery. Additional drapes 155 can be adhesively attached to thebag 153 so that the surgical procedure can be performed on the knee. Inother embodiments, it may be desirable to remove all materials from theincision zone of the limb 135. With reference to FIG. 49, the patientcan be moved into the OR and the knee portion of the bag 153 can then becompletely removed from the entire perimeter of the knee area of the leg135 for the surgical procedure.

In other embodiments the sheet 147 is wrapped around the limb and onlythe edges of the sheet 147 are secured to each other and the upper endof the bag is secured to the upper portion of the leg as shown in FIG.50. Most of the leg 135 can be within the non-adhesive area 151 of thesheet 147 and surrounded by the adhesive area 149. The adhesive area 149of the sheet 147 can be secured together and the adhesive area 149 canform a seal against a perimeter of the proximal portion of the leg 135.In an embodiment, a sponge 157 can be saturated with a sterile solutionand can be placed within the bag 153 and the sponge 157 can be graspedfrom outside the bag 153 and scrubbed against the leg 135 to sterilizethe leg 135.

With reference to FIG. 51, in an embodiment, the bag 153 can be coupledto a clean air inlet 141 and air outlets 143. The inlet 141 ispositioned above the knee and the outlets 143 are by the foot and theproximal end of the bag. In an embodiment, a sponge 157 can be placedwithin the bag 153 and a sterilization fluid can be injected into thebag 153. The limb 135 can be cleaned and then dry sterile filtered aircan flow into the bag 153 through the knee vent inlet 141 and vented outof the bag at the outlets 143 at the ends. The air flow can dry thesterilized leg 135 prior to surgery.

Again, the inner surfaces of the sheet 147 can have adhesive areas 149and non-adhesive surfaces 151. In this example, the inner surface by theperimeter of the sheet 147 can be coated with an adhesive 149 but thearea of the sheet 147 in the area of the leg 151 can not be coated withan adhesive 149 so that when the bag 153 is opened, the bag 153 willpeal away without sticking to the skin of the leg 135 of the patient. Inan embodiment, the bag 153 can be opened in a way that the bag itselfwill form part of the drape.

In different embodiments, the inventive system can be used for specificapplications. In order to improve the efficiency of operations, thepatient's time in the OR should be minimized. By moving surgical stepsthat are needed such as sterilization of an incision area of a patientoutside of the OR, the efficiency can be substantially increased and thecosts for surgeries can be reduced.

These processes can be described with reference to the flowchartillustrated in FIG. 52. The process steps can be outside of the OR 187or inside the OR 189. For example, a patient can be prepared for surgeryoutside the OR 171. The pre-drape apparatus is applied over the incisionarea of the patient 173. In some embodiments, the pre-drape apparatuscan be a planar structure that is placed on a portion of the patient'sbody. In other embodiments, the pre-drape apparatus can be a bag typestructure that is placed around a limb of the patient. The pre-drapeapparatus can have a sealing adhesive that isolates the incision area orlimb from the non-sterile surroundings. A sterilization solution can beused to sterilize the incision area of the patient 175. Once theincision area in the aperture is cleaned, this area can be dried and anyresidual sterilization solution can be drained 177. The patient can thenbe moved to the OR 179. When the surgery is ready to proceed, the upperlayer of the pre-drape apparatus is removed 181. Additional drapes canbe attached to the pre-drape apparatus 183. Once the drapes are set up,the surgery is performed 185.

A variation on the process illustrated in FIG. 52 can be described withreference to the flowchart illustrated in FIG. 53. In this example, apatient can be prepared for surgery outside the OR 191. A sterilizationsolution can be used to sterilize the incision area of the patientbefore the pre-drape apparatus is applied. Once the incision area in theaperture is cleaned, this area can be dried 195. The pre-drape apparatusis when applied over the sterilized incision area of the patient tomaintain the sterilized state 197. The patient can then be moved to theOR 179. When the surgery is ready to proceed, the upper layer of thepre-drape apparatus is removed 181. Additional drapes can be attached tothe pre-drape apparatus 183. Once the drapes are set up, the surgery isperformed 185.

As discussed, it can be useful to perform as many procedures outside theOR as possible. These out of OR procedures can vary depending upon theneeds of the patient. One example of an application is for epidurals forwomen who are in labor with reference to FIG. 54. Some process stepsoccur outside the labor and delivery room 217 while other steps occur inthe labor and delivery room 219. In this application, the patient isprepared for delivery outside the labor and delivery room 201. Asterilization solution is used to sterilize an epidural area of thepatient and then dried 203. The pre-drape apparatus can be applied overthe epidural area of the patient 205. A topical analgesic can be appliedand then the epidural can be given to the patient 207. In an embodiment,the needles for the epidural can be administered through a needle portin the upper layer of the pre-drape apparatus. If additional epidural isneeded, the needle port in the pre-drape apparatus can be used again.The patient can then be moved into the labor and delivery room 209. Thepre-drape apparatus can be removed 211 and the delivery can be performed213.

It will be understood that the inventive system has been described withreference to particular embodiments; however additions, deletions andchanges could be made to these embodiments without departing from thescope of the inventive system. Although the systems that have beendescribed include various components, it is well understood that thesecomponents and the described configuration can be modified andrearranged in various other configurations.

What is claimed is:
 1. A multi-layered pre-drape comprising: a lowerlayer with an aperture; a middle layer having a flat section thatsurrounds the aperture and a folded drape section surrounds the flatsection of the middle layer wherein the folded drape section isexpandable from a folded configuration into an unfolded configurationthat drapes outward; an upper layer that is a sterile cover that coversthe middle layer, the lower layer, and the aperture which are sterile,wherein the upper layer covers the folded drape section and holds thefolded drape section in place; a first adhesive that is configured tosecure a lower surface of the lower layer to a patient with a surgicalarea within the aperture of the lower layer; and a second adhesive thatsecures a lower surface of the upper layer to an upper surface of thelower layer and an upper surface of the flat section of the middle layerwherein an adhesive strength of the first adhesive is greater than thesecond adhesive.
 2. The multi-layered pre-drape of claim 1 wherein anupper surface of the upper layer is not sterile and the lower surface ofthe upper layer, the first adhesive, the lower layer and the secondadhesive are sterile.
 3. The multi-layered pre-drape of claim 1 whereinthe upper layer over the aperture is transparent.
 4. The multi-layeredpre-drape of claim 1 wherein when the perimeter of the upper layer isopened, the folded sections of the middle layer is unfolded andexpanded.
 5. The multi-layered pre-drape of claim 1 further comprising:a hermetically sealed sterile package wherein the lower layer and themiddle layer are hermetically sealed in the hermetically sealed sterilepackage.